title: EARLY Treatment with azilsartan compared to ACE-inhibitors in anti-hypertensive therapy--rationale and design of the EARLY hypertension registry.
abstract: BACKGROUND
  Arterial hypertension is highly prevalent but poorly controlled. Blood pressure (BP) reduction substantially reduces cardiovascular morbidity and mortality. Recent randomized, double-blind clinical trials demonstrated that azilsartan medoxomil (AZM) is more effective in reducing BP than the ubiquitary ACE inhibitor ramipril. Therefore, we aimed to test whether these can be verified under clinical practice conditions.
  
  
  METHODS
  The "Treatment with Azilsartan Compared to ACE-Inhibitors in Anti-Hypertensive Therapy" (EARLY) registry is a prospective, observational, national, multicenter registry with a follow-up of up to 12 months. It will include up to 5000 patients on AZM or ACE-inhibitor monotherapy in a ratio of 7 to 3. A subgroup of patients will undergo 24-hour BP monitoring. EARLY has two co-primary objectives: 1) Description of the safety profile of azilsartan and 2) achievement of BP targets based on recent national and international guidelines for patients treated with azilsartan in comparison to those treated with ACE-inhibitors. The most important secondary endpoints are the determination of persistence with treatment and the documentation of cardiovascular and renal events. Recruitment commenced in January 2012 and will be completed by February 2013.
  
  
  CONCLUSIONS
  The data obtained will supplement previous results from randomized controlled trials to document the potential value of utilizing azilsartan medoxomil in comparison to ACE-inhibitor treatment for target BP achievement in clinical practice.
authors.affiliation: Stiftung Institut für Herzinfarktforschung, Bremser Strasse 79, 67063 Ludwigshafen, Germany. gitta@klilu.de
authors.forename: Anselm K
authors.initials: AK
authors.lastname: Gitt
authors.forename: Peter
authors.initials: P
authors.lastname: Baumgart
authors.forename: Peter
authors.initials: P
authors.lastname: Bramlage
authors.forename: Felix
authors.initials: F
authors.lastname: Mahfoud
authors.forename: Sebastian A
authors.initials: SA
authors.lastname: Potthoff
authors.forename: Jochen
authors.initials: J
authors.lastname: Senges
authors.forename: Steffen
authors.initials: S
authors.lastname: Schneider
authors.forename: Hartmut
authors.initials: H
authors.lastname: Buhck
authors.forename: Roland E
authors.initials: RE
authors.lastname: Schmieder
mesh_terms: D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000627:therapeutic use*; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000453:epidemiology; D010069:Oxadiazoles / Q000627:therapeutic use*; D011446:Prospective Studies; D012042:Registries; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D001562:Benzimidazoles; D010069:Oxadiazoles; C521273:azilsartan